Comparison of Rapid Antigen Tests for COVID-19

Seiya Yamayoshi(The University of Tokyo), Yuko Sakai‐Tagawa(The University of Tokyo), Michiko Koga(University of Tokyo Hospital), Osamu Akasaka(Fujisawa City Hospital), Ichiro Nakachi(Saiseikai Utsunomiya hospital), Hidefumi Koh(Tachikawa Hospital), Kenji Maeda(National Center for Global Health and Medicine), Eisuke Adachi(University of Tokyo Hospital), Makoto Saito(University of Tokyo Hospital), Hiroyuki Nagai(University of Tokyo Hospital), Kazuhiko Ikeuchi(University of Tokyo Hospital), Takayuki Ogura(Saiseikai Utsunomiya hospital), Rie Baba(Saiseikai Utsunomiya hospital), Kensuke Fujita(Saiseikai Utsunomiya hospital), Takahiro Fukui(Tachikawa Hospital), Fumimaro Ito(Tachikawa Hospital), Shin-ichiro Hattori(National Center for Global Health and Medicine), Kei Yamamoto(National Center for Global Health and Medicine), Takato Nakamoto(National Center for Global Health and Medicine), Yuri Furusawa(The University of Tokyo), Atsuhiro Yasuhara(The University of Tokyo), Michiko Ujie(The University of Tokyo), Shinya Yamada(The University of Tokyo), Mutsumi Ito(The University of Tokyo), Hiroaki Mitsuya(National Center for Global Health and Medicine), Norio Omagari(National Center for Global Health and Medicine), Hiroshi Yotsuyanagi(University of Tokyo Hospital), Kiyoko Iwatsuki‐Horimoto(The University of Tokyo), Masaki Imai(The University of Tokyo), Yoshihiro Kawaoka(University of Wisconsin–Madison)
Viruses
December 10, 2020
10.3390/v12121420
Cited by 226Open Access
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Abstract

Reverse transcription-quantitative PCR (RT-qPCR)-based tests are widely used to diagnose coronavirus disease 2019 (COVID-19). As a result that these tests cannot be done in local clinics where RT-qPCR testing capability is lacking, rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are used for rapid diagnosis. However, their sensitivity compared with each other and with RT-qPCR and infectious virus isolation has not been examined. Here, we compared the sensitivity among four RATs by using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) isolates and several types of COVID-19 patient specimens and compared their sensitivity with that of RT-qPCR and infectious virus isolation. Although the RATs read the samples containing large amounts of virus as positive, even the most sensitive RAT read the samples containing small amounts of virus as negative. Moreover, all RATs tested failed to detect viral antigens in several specimens from which the virus was isolated. The current RATs will likely miss some COVID-19 patients who are shedding infectious SARS-CoV-2.

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